Barosinusitis due to routine weather changes: A cross-sectional analysis of public websites.

Background: Sinusitis is a common diagnosis that can be erroneously associated with routine weather-related barometric pressure changes. In actuality, these pressure changes likely exacerbate migraine headaches, which can cause facial pain and pressure rather than true sinus inflammation. Objective: The present study sought to characterize the representation of both sinusitis and migraine in association with barometric pressure changes across websites on the Internet. Methods: An Internet search for relevant terms was conducted, and content of the resulting pages was assessed for associations between weather-related pressure changes and either sinusitis or migraine. Variations in reported results across different subtypes of Internet sources were analyzed. The primary outcomes measured were (1) whether a given media source associated barometric weather changes with sinusitis, (2) whether that source associated barometric weather changes with migraine, and (3) treatment options offered by that source. Results: Of the 116 included webpages, 36 (31.03%) associated sinusitis and routine barometric pressure changes. Of these, 10 (27.77%) were otolaryngology practice sites. Sixty-seven webpages (57.76%) associated migraine and routine barometric pressure changes. Of these, nonotolaryngology webpages were more likely to report this link. Conclusions: Otolaryngology practice sites were observed to be the most frequent professional medical resource reporting the unsubstantiated claim that routine barometric pressure changes are associated with sinusitis. Nonotolaryngology sources were more likely to link weather-related pressure changes to migraine. These results suggest that opportunities exist for otolaryngology practice sites to educate patients about nonrhinogenic headache etiologies.

Hydraulic dissection technique during endoscopic sinus surgery using a novel balloon sinus dilation device.

BACKGROUND: More than a decade after its introduction, some rhinologic surgeons have incorporated the technique of balloon sinus dilation (BSD) technology into "hybrid" endoscopic sinus surgery (ESS) procedures. A novel BSD device which can be placed over standard surgical instruments, including surgical navigation instruments, has recently been introduced. We present a case series in which this device was used as a hydraulic dissection tool to aid safe efficient surgery in difficult-to-access locations of the paranasal sinuses during hybrid ESS procedures. OBJECTIVE: Highlight the potential role of hydraulic dissection techniques during ESS utilizing BSD. METHODS: Retrospective case series of patients who underwent ESS performed in part with a novel BSD device. RESULTS: A total of 10 patients who underwent hybrid ESS with BSD were reviewed. In all 10 cases, the novel BSD device was used without complication. The device was used over straight and curved suctions while being tracked with surgical navigation in all cases. Thirteen posterior ethmoid dissections, 12 sphenoidotomies, and 8 frontal sinusotomies were assisted with the device. For the selected dissections in which the balloon was utilized, the operating surgeon found it to be helpful in creating more space in difficult to access areas which allowed for continued safe surgical dissection. CONCLUSIONS: Sinus balloon devices can be used as a hydraulic dissection tool and may be a useful adjunct during ESS. The novel dilation system used in this study, which deploys a sinus balloon device over standard surgical instruments with surgical navigation, provides even more opportunity to accurately dissect difficult areas of the paranasal sinuses safely and efficiently. Further studies evaluating the exact role of sinus balloon devices used as a hydraulic dissection tool during ESS are warranted. LEVEL OF EVIDENCE: 4.

Balloon sinuplasty in one-day surgery.

INTRODUCTION: Balloon sinus dilation is becoming an increasingly common procedure, finding a niche as an invaluable tool in endoscopic sinus surgery. AIM: To assess the effectiveness of balloon sinus dilation (BSD) in 1-day surgery in patients with chronic rhinosinusitis without polyps based on our own experience. MATERIAL AND METHODS: The study group consisted of 9 patients. The Lund-Mackay scale for computed tomography of the paranasal sinuses was assessed prior to surgery. Endoscopy was performed on the basis of the Lund-Kennedy scale and patients were asked to perform the SNOT-22 survey. Two patients underwent balloon sinuplasty under general and seven under local anaesthesia. RESULTS: Twelve maxillary and eight frontal sinuses were widened (four attempts were unsuccessful). The SNOT-22 survey was assessed the day after surgery (average of 8 points) and a month after surgery (average of 15.5 points). CONCLUSIONS: BSD only allows widening of the ostia of the maxillary, frontal and sphenoid sinuses. BSD offers shorter post-surgical recovery, and a more rapid return to work because of its less invasive and less traumatic nature.

Management of Recurrent Acute Rhinosinusitis: A Systematic Review.

BACKGROUND OBJECTIVE STUDY DESIGN: RARS is a challenging clinical problem that impacts many patients. This article seeks to systematically review the literature on RARS management. METHODS: Cochrane, PubMed, EMBASE, and other databases were queried for articles related to RARS dating from 1990 to present, according to PRISMA guidelines. Inclusion criteria included articles specifically addressing RARS management; studies with 3 or more patients; and articles in English. RESULTS: A total of 1022 titles/abstracts potentially related to RARS were identified. Of these, sixty-nine full texts were selected for review, and 10 met inclusion criteria (five with level 4 evidence, four with level 3 evidence, one with level 2 evidence). The studies included a total of 890 patients (Age range 5.8 to 53.5 years), with follow up ranging from 1 to 19 months. Endpoints were primarily based on symptomatic improvement, although some articles also reported post-treatment endoscopic and radiographic findings. Management options included medical therapy (intranasal steroids, antibiotics, nasal saline irrigations, N-acetylcysteine, allergy treatment, and decongestants), balloon sinus dilation (BSD), and endoscopic sinus surgery (ESS). Surgical patients (BSD and ESS) had a trend towards greater symptom control than medically-treated patients, but meta-analysis was not possible. CONCLUSION: Despite increasing interest in the treatment of RARS, there remains a lack of consensus regarding optimal management. The literature thus far, largely based on expert opinion, suggests that surgical management, either through balloon sinus dilation or endoscopic sinus surgery, may be helpful in improving symptoms and quality of life in those who do not respond to initial trials of medical management.

Radiologic Analysis of Balloon Sinuplasty in a Human Cadaver Model: Observed Effects on Sinonasal Anatomy.

BACKGROUND: Balloon sinuplasty is increasingly used in the outpatient clinic for treatment of chronic rhinosinusitis, but radiologic analysis of its effects on sinonasal anatomy is largely uncharacterized in the known literature. OBJECTIVE: The purpose of this study is to examine the anatomic effects of balloon sinuplasty in a cadaveric model. METHODS: Five fresh cadaver heads underwent sequential endoscopic balloon dilation of maxillary ostia, frontal recess outflow tracts, and sphenoid ostia bilaterally by fellowship-trained rhinologists. Pre- and post-procedural CT imaging was obtained. CT scans were imported into Mimics™ software and sinonasal anatomy was analyzed systematically. RESULTS: Visual confirmation of balloon dilation was achieved in all 3 sites bilaterally in each cadaver. Radiologic analysis demonstrated that the frontal sinus outflow tract was appropriately dilated 60% (6/10 sites) of the time while the agger was inadvertently dilated 30% of the time (3/10). The sphenoid os was successfully dilated 70% (7/10 sites) of the time. In two cases, a posterior sphenoethmoid (Onodi) cell was dilated instead of the sphenoid. Successful dilation of maxillary os was noted 60% of the time (6/10 sites). No significant change in maxillary os was noted after balloon dilation. Normal middle turbinates were significantly medialized following balloon dilation 75% (6/8 sites) of the time. CONCLUSIONS: While the goal of balloon sinuplasty is to improve natural sinonasal drainage by dilating existing outflow tracts, as evidenced by radiologic evaluation the procedure appears not to achieve this in all cases, while occasionally creating unintended changes in sinonasal anatomy as well. These unrecognized changes in anatomy may be responsible for the post-procedure change in symptomatology that some patients experience.

The use of balloon dilation in revision sinus surgery.

BACKGROUND: Recent studies have demonstrated a dramatic increase in the use of balloon sinus dilation (BSD) in the United States. However, the use of BSD specifically in revision sinus surgery has not been investigated. This study addresses the question of how BSD is utilized as a tool in revision sinus surgery. METHODS: Data from MarketScan (Truven Health) over a 5-year period (2012-2016) were analyzed. Patients who underwent a sinus procedure with a minimum of 2 years of follow-up were included. RESULTS: A total of 62,304 patients met inclusion criteria; 6847 (10.99%) underwent revision. Age >55 years, the South geographical region, and medical comorbidities increased the odds of revision on multivariate analysis. For patients undergoing revision, BSD was used 11%, 21%, and 13% of the time for revisions of the maxillary, frontal, and sphenoid sinuses, respectively. For a sinus that underwent revision after an initial BSD, a repeat BSD was done close to 40% of the time. CONCLUSION: BSD is used frequently in the revision setting, especially for the frontal sinus and for patients who had already undergone an initial BSD. Our findings highlight the prevalent role of BSD in revision surgery and the need to evaluate such practices.

"In-Office Balloon Sinus Ostial Dilation with Concurrent Antiplatelet and Anticoagulant Therapy for Chronic Rhinosinusitis without Nasal Polyps".

OBJECTIVE: Functional endoscopic sinus surgery (FESS) and balloon sinus ostial dilation (BSD) are well-recognized minimally invasive surgical treatments for chronic rhinosinusitis without nasal polyps (CRSsNP) refractory symptoms to medical therapy. Patients on antiplatelet and anticoagulant therapies (AAT) usually are recommended to discontinue their medications around the period of endoscopic sinus surgery. The goal of this study is to assess the clinical experience of BSD in CRSsNP patients with concurrent anticoagulant or antiplatelet therapy. METHODS: A review of prospectively-collected clinical data from October 2012 to March 2017 were used to perform a cohort study of subjects with CRSsNP who met criteria for surgical intervention while on antiplatelet and anticoagulant therapy. Data were collected on demographics, details of the procedures, type of AAT used, pre- and postoperative 22-item Sino-Nasal Outcome Test (SNOT-22) scores, and complications. RESULTS: Thirty-five patients underwent in-office BSD while on antiplatelet and/or anticoagulant therapy. The mean difference in pre- and postoperative SNOT-22 scores of 9.9 (SD 14.4, P < .001) was both statistically significant and exceeded the minimal clinically important difference of 8.9. Absorbable nasal packing was used for persistent bleeding immediately post-procedure in two patients. Intraoperative bleeding was associated with aspirin 325 mg and warfarin. FESS was required for further management of chronic sinusitis in four patients after anticoagulant/antiplatelet therapy could be discontinued. There were no systemic complications. None of the patients experienced significant bleeding events postoperatively after leaving the office. CONCLUSION: In-office BSD appears to be a safe alternative to endoscopic sinus surgery in select patients who cannot discontinue antiplatelet and anticoagulant therapy. LEVELS OF EVIDENCE: IV.

The intraoperative accuracy of maxillary balloon dilation: a blinded trial.

BACKGROUND: Balloon sinus dilation (BSD) is a commonly performed sinus procedure in the United States. Several cadaveric studies have evaluated BSD accuracy and the maxillary sinus has consistently been shown to be the most challenging to cannulate. We designed an independent study to evaluate the intraoperative accuracy of maxillary sinus BSD. METHODS: A prospective, single-blinded trial evaluating the accuracy of maxillary sinus BSD was performed using 2 commercially available BSD systems (guidewire- and probe-based systems) randomly assigned to patients undergoing endoscopic surgery for chronic rhinosinusitus without nasal polyps (CRSsNP) or a skullbase approach in patients without sinus disease. All patients underwent maxillary BSD followed by uncinectomy to reveal dilation of the natural maxillary sinus ostia. The recorded procedures were reviewed by 3 fellowship-trained rhinologists from different institutions blinded to the BSD system utilized. The primary endpoint compared accuracy of maxillary BSD attempts. The secondary endpoint compared accuracy between the 2 systems. RESULTS: Twenty-nine maxillary BSD procedures were performed in 18 patients (age range, 20-79 years; mean, 51 years) without nasal polyposis undergoing maxillary antrostomy as part of a more extensive procedure. BSD was successful in 18 of 29 (62%) attempts and unsuccessful in 9 of 29 (31%) attempts, with statistically "almost perfect" interrater agreement (kappa = 0.86). There was no statistical difference between the 2 BSD systems (p = 0.81). CONCLUSION: Maxillary BSD appeared to be less accurate in living patients when compared with findings from previously published cadaver studies. There were no differences in accuracy between the probe- and guidewire-based systems. This is the first non-industry-sponsored study evaluating maxillary sinus BSD in living patients. Further studies are needed to investigate the clinical implications of our findings.

Factors Associated with Revision Surgery after Balloon Sinuplasty.

OBJECTIVE: Although balloon sinuplasty (BSP) is increasing in popularity, little is known about which patients are the ideal candidates. The objective of this study is to investigate factors that may be associated with BSP failure. STUDY DESIGN: Retrospective review. SETTING: Academic center. SUBJECTS AND METHODS: This is a 6-year (July 2011-June 2017) retrospective review of patients who underwent BSP or revision endoscopic sinus surgery (rESS) after BSP within a single tertiary health system. Demographics, clinical findings, and radiographic findings were investigated for association with rESS via univariate analyses and a multivariable backward elimination selection procedure. RESULTS: A total of 154 patients were identified (median age, 53 years): 146 patients underwent BSP at a single health system, with 16 (11%) undergoing rESS; 8 patients underwent BSP at an outside institution and underwent rESS with the senior author. Mean ± SD follow-up was 12.8 ± 16.6 months. Univariate analyses revealed that prior endoscopic sinus surgery, polyps, allergic rhinitis, and gram-negative infection were significantly associated with rESS. As for radiographic findings, a higher Lund-Mackay score, neo-osteogenesis, moderate or complete opacification, and hyperdensities were associated with rESS. The final model after multivariable selection showed that higher radiographic scores (odds ratio, 1.08; 95% CI, 1.01-1.17) and neo-osteogenesis (odds ratio, 5.25; 95% CI, 1.68-16.42) were associated with higher odds for rESS. CONCLUSIONS: This study identifies several clinical and radiographic factors that may be associated with the need for rESS after BSP. Surgeons can take these factors into consideration when deciding whether a patient should forego BSP and undergo conventional FESS.

Innovations in Balloon Catheter Technology in Rhinology.

Since being introduced more than 10 years ago, balloon catheter technology (BCT) has undergone several generations of innovations. From construction to utilization, there has been a myriad of advancements in balloon technology. The ergonomics of the balloon dilation systems have improved with a focus on limiting the extra assembly. "Hybrid" BCT procedures have shown promise in mucosal preservation, including treating isolated complex frontal disease. Multiple randomized clinical trials report improved long-term outcomes in stand-alone BCT, including in-office use. The ever-expanding technological innovations ensure BCT will be a key component in the armamentarium of the modern sinus surgeon.

An Analysis of Adverse Event Reporting in Balloon Sinus Procedures.

OBJECTIVE: (1) Become familiar with reported adverse events related to balloon dilation of the paranasal sinus ostia. (2) Understand the sequelae occurring with these events. STUDY DESIGN: Retrospective analysis of a prospective database. SETTING: OpenFDA database. SUBJECTS AND METHODS: The OpenFDA program website of the Food and Drug Administration was queried with the Application Program Interface query system for medical device adverse events involving balloon devices for the dilation of paranasal sinus ostia from January 2006 through December 2014. The raw data were then tabulated, with adverse events codified by event type, sinus involved, injury type, device malfunction, surgeon error, and qualitative data. Sequelae were also quantified. RESULTS: In sum, 114 adverse events were identified. Patient injury was the most frequently reported adverse event (n = 72), followed by 36 device malfunctions, 4 deaths, and 2 unclassified. The most common injury involved orbital complications, including 23 (20.2%) orbital wall fractures and 22 (19.3%) postseptal and 22 (19.3%) preseptal orbital injuries. In addition, there were 17 (14.9%) skull base injuries and 7 (6.1%) cases of severe epistaxis observed; 11 (9.6%) cases mentioned surgeon error. Cerebrospinal fluid leak was significantly associated with frontal surgery (P = .002) and sphenoid surgery (P = .001), whereas post- and preseptal orbital injury was associated with maxillary surgery (P = .017 and P = .002). Epistaxis was associated with sphenoid surgery (P = .032). CONCLUSIONS: Based on the number of balloon sinus procedures performed, Food and Drug Administration-reported adverse events are uncommon, although a select portion can be severe. Surgeons should be aware of different complications reported with specific sinuses addressed with balloon techniques.

REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies.

OBJECTIVES/HYPOTHESIS: To provide the final results from the REMODEL (randomized evaluation of maxillary antrostomy versus ostial dilation efficacy through long-term follow-up) full-study cohorts and perform meta-analyses of standalone balloon sinus dilation studies to explore long-term outcomes in a large patient sample. STUDY DESIGN: Randomized controlled trial and meta-analysis. METHODS: Final outcomes from the REMODEL randomized trial, including a larger cohort of 135 patients treated with functional endoscopic sinus surgery (FESS) or in-office balloon dilation, were evaluated. One hundred thirty patients had 12-month data, 66 had 18-month data, and 25 had 24-month data. In addition, a meta-analysis evaluated outcomes from six studies including 358 standalone balloon dilation patients with up to 24 months follow-up. RESULTS: Outcomes out to 2 years from the REMODEL full-study cohort are consistent with 6-month and 12-month outcomes. In the meta-analysis of standalone balloon dilation studies, technical success is 97.5%, and mean 20-item Sino-Nasal Outcomes Test scores are significantly and clinically improved at all time points (P < .0001). There are significant reductions (P < .0001) in work/school days missed, homebound days, physician/nurse visits, acute infections, and antibiotic prescriptions. Mean recovery time is 1.4 days. Comparison of 12-month symptom improvements and revision rates between the REMODEL FESS arm (n = 59), REMODEL balloon dilation arm (n = 71), and pooled single-arm standalone balloon dilation studies (n = 243) demonstrated no statistical difference. CONCLUSIONS: All outcomes are comparable between FESS and balloon dilation at all time points from 6 months to 24 months. Balloon dilation produces faster recovery, less postoperative pain, and fewer debridements than FESS. There is significant, durable benefit in a large series of 358 patients undergoing standalone balloon dilation.

Office-Based Balloon Sinus Dilation: 1-Year Follow-up of a Prospective, Multicenter Study.

OBJECTIVE: Balloon sinus dilation (BSD) instruments afford the opportunity for office-based sinus procedures in properly selected patients with chronic rhinosinusitis (CRS). This study evaluated patient-reported outcomes 1 year after office-based BSD. METHODS: Adult patients with medically refractory CRS were prospectively enrolled into a multicenter, single-arm study and treated with office-based BSD under local anesthesia. Follow-up on 203 patients was conducted at 2, 8, and 24 weeks postsurgery using validated outcome measures for quality of life (SNOT-20) and computed tomography imaging (Lund-Mackay score). After 24 weeks, patients were re-enrolled for 1-year follow-up to evaluate changes in SNOT-20 scores and revisions. RESULTS: All patients who re-enrolled (n = 122) completed the study, with an average follow-up of 1.4 years. Neither preoperative SNOT-20 nor Lund-Mackay CT scores were predictive of re-enrollment and return for follow-up. Compared to baseline, improvements in SNOT-20 scores remained statistically significant (P < .001) and clinically meaningful (mean decrease ≥ 0.8). In patients followed to 1.4 years, 9 of 122 (7.4%) had revision surgery. CONCLUSION: Following office-based BSD, significant improvements in quality of life observed at 24 weeks were maintained 1 year postsurgery. These extended results provide further evidence of office-based BSD as an effective, minimally invasive procedure for appropriately selected patients with CRS.

Use of a Foley catheter balloon as a tool during endoscopic frontal sinus surgery in a resource-poor environment.

OBJECTIVE: This study aimed to evaluate the non-Food and Drug Administration-approved off-label use of a 10F Foley catheter as a tool during endoscopic frontal sinus surgery. METHOD: A cohort of 40 patients with chronic frontal rhinosinusitis was prospectively evaluated using the Sino-Nasal Outcome Test (SNOT-22), computed tomography (CT) imaging, and endoscopic examination. Endoscopic sinus surgery (ESS) was performed in the usual fashion, however, when approaching the frontal sinus, a 10F Foley catheter was inserted and the balloon inflated in the frontal outflow. Patients were assessed postoperatively with SNOT-22, CT imaging, and endoscopic assessment at 6 months. RESULTS: Successful intraoperative dilation of the frontal recess was achieved in 62 of 69 frontal sinuses (90%). No cerebrospinal fluid leak or orbital entry occurred. Six months postoperative, SNOT-22 scores showed significant improvement, whereas endoscopic assessment revealed patent frontal recess in 55 of 62 (89%) frontal sinuses. Computed tomography imaging was completed in 25 patients comprising 41 operated frontal sinuses with no mucosal thickening seen in 37 of 41 (90%). CONCLUSION: The 10F Foley catheter is an effective tool to dilate the frontal recess by compression of edema during ESS. It may be a safe and cost-effective alternative to high-cost commercially available sinus balloons, especially in resource-poor environments.

Operative utilization of balloon versus traditional endoscopic sinus surgery.

OBJECTIVES/HYPOTHESIS: To study the utilization of balloon catheter dilation (BCD) compared to traditional endoscopic sinus surgery (ESS) STUDY DESIGN: Cross-sectional analysis METHODS: Cases identified by Current Procedural Terminology codes as BCD (2,717) or traditional ESS (31,059) were extracted from the State Ambulatory Surgery Databases 2011 for California, Florida, Maryland, and New York. Patient demographics, surgical center and surgeon volume, mean charge, and operating room (OR) time were compared. RESULTS: There were 33,776 patients who underwent sinus surgery in the included states in 2011. Of these, 4.6% of maxillary, 5.6% of sphenoid, and 13.9% of frontal procedures were performed using BCD. Adjusted analyses found increased use of BCD in patients with chronic diseases(P < .001). Patients who had limited sinus surgery were less likely to have BCD compared to patients who had all four sinuses instrumented (P < .001). Surgeons who performed a medium (odds ratio 1.38 [1.14-1.65]) or high (odds ratio 1.71 [1.42-2.07]) volume of ESSs were more likely to use BCD compared to those who performed a low volume (P < .001). However, among surgeons who utilized BCD, there was a minimal relationship between the percentage of surgeries performed with BCD and the surgeon's total number of cases (R(2) = 0.055). Compared to traditional ESS, the median charges for maxillary/ethmoid procedures (mini-ESS) involving BCD were approximately $4,500 (P < .001) and maxillary/ethmoid/sphenoid/frontal procedures (pan-ESS) were approximately $2,950 (P = .003) greater, whereas the median OR time involving BCD was 8 minutes less for mini-ESS procedures(P = .01) but not statistically different for pan-ESS procedures (P = .58). CONCLUSIONS: In the study sample, balloon technology was used in 8.0% of ESS cases in 2011. Procedures using BCD were on average more expensive compared to traditional ESS procedures, with minimal decrease in OR time.